MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. SARA PLUS; LIFT, PATIENT, NON-AC-POWERED

Model Number	HEP0001-US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided upon investigation conclusion.
Event or Problem Description
It was reported that the battery on the lift was not locking in place and fell out of the device.No injury was reported.
Additional Manufacturer Narrative
Additional information will be provided upon investigation conclusion.
Additional Manufacturer Narrative
It was reported that the sara plus floor lift battery dislodged from the lift and fell out of the device.There was no patient involved.No injury was claimed.The instruction for use for sara plus (kkx52180m) contains warning: "if any doubt about the correct functioning of the sara plus, withdraw it from use and contact arjo service department." "visualy inspect sara plus.If any part is damaged-do not use the product." the arjo technician evaluated the device and confirmed that the battery fell out because the lift cover was out of place.Therefore, the battery on the lift was not locking in place.It is unknown why the lift cover was out of place.The arjo technician adjusted the outer console housing on the device.Based on the information obtained during the course of the investigation, the exact root cause of the battery falling out cannot be established.In summary, the arjo device failed to meet its performance specification since the sara plus battery fell out from the device.There was no patient involved.The complaint was reportable due to indication that the battery fell out from the device.

• Brand Name: SARA PLUS
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 21604505
• Report Number: 3007420694-2025-00083
• Device Sequence Number: 15735152
• Product Code: FSA
• UDI-Device Identifier: 05055982787420
• UDI-Public: (01)05055982787420(11)220512
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HEP0001-US
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/11/2025; 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown